Mind your Moles Study / Brisbane Electoral Roll Naevus Study (BERNS)
Centre of Research Excellence (CRE)
Start / End Date: 2016 to 2019
The CRE Core Study (Mind your Moles Study) engages all CRE staff and links the three research Programs.
The Core Study is a prospective longitudinal population-based cohort study of the natural history of naevi in adults living in Brisbane, Australia (Brisbane Electoral Roll Naevus Study BERNS, also called the Mind your Moles Study). Up to 150 participants will be followed for three years.
Participants will be recruited from the state electoral roll for residents of greater Brisbane.
Baseline study procedures: Participants will receive a clinical skin examination and will also undergo 3-D total body photography, using the Canfield VECTRA whole body scanner, providing a highly standardised and reproducible record of all naevi. We have one of only two such scanners that are available worldwide. Individual naevi larger than 5mm will be dermoscopically recorded using the FotoFinder System. Participants will be asked to provide saliva samples for genomic DNA and to complete a skin self-examination (SSE) every three months, noting spots or moles of concern.
Follow-up: To evaluate changes in naevi, participants will return for regular follow-up every six months for up to three years, when baseline procedures will be repeated. The CRE team will compare naevi against their baseline, and record the number of unchanged, changed or new. Furthermore, any changed naevi will be classified as having alterations in size, colour, shape, or changes in their dermoscopic features.
Mobile teledermoscopy follow-up: Feasibility studies indicate that mobile teledermoscopy may be effective to improve early diagnosis of melanoma or to replace some face to face visits during follow-up. In a nested randomised trial within the cohort study, half of the participants will be randomised to receive a mobile dermoscope for their SSE. This is a magnifying device attached to a mobile phone with polarised light and an app to store or send photos to a dermatologist. It can aid the SSE, guiding participants to look at each lesion carefully. Clinically trained members of the CRE team will independently provide a telediagnosis for each submitted naevus to assess diagnostic accuracy, and to train clinical fellows in teledermatology. A sample of participants who conduct SSE, with or without the mobile dermoscope, will be interviewed in-depth about their naevi selection to provide insight into the cognitive processes involved.
Donation of naevus samples: Participants will be asked to consider donating one or two of their naevi (for example, one changed and one stable naevus). Each naevus will first be microbiopsied in-vivo, using the device developed by A/Prof Prow, with further ex-vivo microbiopsies after excision. Each naevus will undergo routine histopathological assessment and molecular biology work-up, and serve as a reference standard for the accuracy of the clinical naevus diagnosis.
Based on our previous reports of naevi counts we expect an average of 30 naevi per person, about 4500 in total (~5% >5mm). If half of the participants donate naevus samples, 150 of these naevi will have histopathological, molecular and genetic work-up, with about five in-vivo and up to 10 ex-vivo microbiopsies per naevus.